Regulatory Affairs (RA) Manager
Breas Medical AB / Kontorsjobb / Härryda
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hela Sverige Breas Medical was founded in Gothenburg, Sweden in 1991. Last year marked the 25th anniversary of providing innovative respiratory medical device products to the global market. Breas successfully marketed the Vivo and iSleep product ranges, the Nippy and Clearway brands, and the Z1 CPAP range, redefining CPAP use in terms of size, weight, and portability. The company is in an expansive phase with an extensive range of new devices and cloud solution to be launched in the near future. Today Breas is a global company with head office in Gothenburg and we are selling in more than 40 countries through our network of subsidiaries (UK, Spain, Germany, USA) and highly specialized distributors. Since 2017, the company is part of Fosun Pharma, a leading Chines player in the field of pharmaceuticals and medical technology.
Regulatory Affairs (RA) Manager
The purpose of this position is to Promote the awareness of regulatory, customer and statutory requirements throughout the organization. Support and develop an awareness of regulatory requirements, product registrations, risk management, the development and implementation of the Quality Management Systems and maintaining its effectiveness.
Essential Job Functions
• Work with regulatory bodies worldwide for regulatory registrations of class I, IIa and IIb medical devices
• Responsible for doing product registrations in EU, US and Rest of the World
• Regulatory representative in new design projects and design changes to define regulatory requirements and assess compliance
• Maintain up-to-date knowledge and understanding of current regulatory requirements of various countries within area of responsibility
• Initiate actions to implement and maintain compliance to applicable regulations
• Promote the awareness of regulatory, customer and statutory requirements throughout the organization
• Mentor, coach & train the organization on activities within Regulatory Affairs
• Support the rest of the department with various tasks within the QA RA area
• Support the implementation of new regulatory requirements such as MDR, MDSAP, ISO 13485:2016 and monitoring of changed regulatory requirements worldwide
• Participate or manage quality and regulatory reviews and quality investigations in QMS processes
• Review and approve labeling
• Aware of and comply with the Quality Management System, Quality Policy, Quality Goals, and applicable laws and regulations.
Basic Qualifications
• Demonstrated experience from working with regulatory bodies and doing product registrations worldwide or at least in major markets such as U.S., Canada, EU, China and Japan. Experience from CE-marking and 510(k) submissions
• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21CFR 820 and ISO 13485
• Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment
• Ability to communicate well in English is required. Swedish is a preference.
Education and/or Experience
• B.S. in Engineering, Engineering Technology, Science a minimum 4 years of experience in Medical device regulated industry . Or high school diploma/GED plus 7 years working experience in Quality or Regulatory Affairs in the medical device industry.
Characteristics
• Strong interest in developing knowledge in regulatory requirements
• Accepting and adhering to high ethical, moral and personal values in decisions, communications, actions and when dealing with others
• Energizing others by building a connection with the team through personal involvement and trust, providing feedback and coaching to help develop others
• Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information.
Varaktighet, arbetstid
Heltid, tills vidare.
Publiceringsdatum2018-03-21Så ansöker duSista dag att ansöka är 0001-01-01
FöretagBreas Medical AB
AdressBreas Medical AB
43533 MÖLNLYCKE
KontorsadressFöretagsvägen 1
Jobbnummer 4037002
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